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Vice President, Quality & Regulatory Affairs

Company: HeartFlow, Inc.
Location: Mountain View
Posted on: November 17, 2023

Job Description:

The Vice President of Quality & Regulatory Affairs will oversee activities pertaining to successful quality systems management and quality affairs, and regulatory affairs supporting pre-market development and submissions, post-market surveillance, and compliance.
The right candidate will possess outstanding operational experience and skills including the demonstrated ability to oversee, design, and improve quality and regulatory processes. Will be responsible for working cross-functionally at all levels of the organization to ensure our systems and procedures are compliant and effective to support an agile development environment.
This position is responsible for activities that lead to and maintain regulatory approval to market devices. Will be responsible for the assessment of device changes for regulatory implications and will develop strategies for submissions and maintenance of documentation within the framework of regulatory requirements worldwide in an efficient manner. Will establish strategic plans and procedures to ensure that the company fulfills its obligations under FDA and international regulations for medical device manufacturers.
A minimum of 15 years, including 10 years in leadership roles, of demonstrable, successful, and relevant experience in quality and regulatory in the medical device industry is required, along with extensive knowledge of both regulatory and quality systems requirements for medical devices including direct experience with regulated software Medical Devices. #LI-IB1
Job Responsibilities:

  • Collaborate with key internal partners and other key stakeholders to support a globally effective and compliant organization.
  • Manage new product registrations / clearances / approvals worldwide
  • Be informed of new regulations and requirements as they relate to continued compliance and interpret for regulatory education and guidance within the organization
  • Provide quality/regulatory education and guidance within the organization
  • Oversee, manage, and respond to regulatory audits
  • Oversee engagement of the quality system management team with HeartFlow's Notified Body for planning and execution of required audits to maintain necessary certifications
  • Ensure suppliers and associated documentation are evaluated to understand quality risk
  • Oversee management of employee training program and work to ensure an efficient effective process
  • Oversee regulatory engagement with the product development process to support the necessary cadence of product releases
  • Proactively manage product quality during the development process
  • Engage with regulatory agencies regarding regulatory submissions
  • Oversee regulatory post-market surveillance to support timely adverse event reporting, product feedback delivery to product teams, and responsiveness to customers
  • Oversee management of the corrective and preventive action process to identify and prevent potential nonconformities, as well as correction/corrective actions
  • Support Quality and Regulatory teams in their day-to-day activities as necessary, providing guidance and decision authority
  • Collaborate cross-functionally to identify and drive process improvements
  • As assigned, serve as designated person responsible for regulatory compliance according to EU MDR (2017/745) Article 15, responsible for ensuring that:

    • the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before device is released;
    • the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
    • the post-market surveillance obligations are complied with in accordance with Article 10(10);
    • the reporting obligations referred to in Articles 87 to 91 are fulfilled;
    • in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.

      Skills Needed:

      • Deep knowledge and understanding of worldwide product regulation/registration pathways, medical device regulations and applicable standards, including but not limited to ISO 13485, ISO 14971, IEC 62304, FDA CFR 21 parts 803 - 820, EU MDR (2017/745), Canadian Medical Devices Regulations.
      • Worldwide product regulation/registration pathways in particular across US, EU, UK, CAN, AUS, and JPN
      • Successful domestic and international regulatory submission track record
      • Experience working with regulated software medical device, including application of 62304 and an agile/scrum development environment
      • Skilled at preparing, reviewing, editing, filing, and supporting various types of submissions including original and supplemental Investigational Device Exemptions (IDEs), Premarket Notifications w/ clinical data, and CE Design and Technical Dossiers.
      • Knowledge of the regulatory requirements to support regulatory resources in determining the best risk management position to take on diverse issues.
      • Common sense approach to creating value through compliance
      • Ability to navigate the "greys" that exist between standards and business practice
      • Approachable and able to interact and influence effectively at technical and management levels
      • Incredible team management skills, ability to lead, train, and mentor team members at all levels. Excellent team player with ability to find and create consensus, and adept at working in the fast pace of a startup environment.
      • Excellent verbal and written communications skills evidenced by short approval times for product submissions and successful interactions with colleagues, consultants, and various regulatory agencies worldwide.
      • Excellent verbal and written communications skills evidenced by short approval times for product submissions and successful interactions with colleagues, consultants, and various regulatory agencies worldwide.
      • Direct experience with external audits/inspections both general audits for compliance and pre-approval inspections for product registrations/submissions
      • We have a talented quality and regulatory team and a strong team culture of respect and collaboration; the right candidate will contribute to this culture and continue to build upon it.

        Educational Requirements & Work Experience:

        • Bachelor's Degree required, Master's Degree preferred
        • 5+ years working with medical devices, familiarity with current regulatory thinking around software and AI
        • Proven track record of building and leading a team of quality and regulatory professionals
        • 15+ years working in regulated industry, including 10+ years management experience, and 5+ years experience with regulated software product/practices

          HeartFlow offers a comprehensive total rewards package, including vacation, sick time, a robust benefits package, 401K, and paid holidays .Exact compensation will depend on various factors (Ex. Certification, Years of Experience, Education, Geography). This position has anestimated base salary range of $230,000 to $300,000 per year.

Keywords: HeartFlow, Inc., Mountain View , Vice President, Quality & Regulatory Affairs, Executive , Mountain View, California

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